Handheld surgical endoscope

ABSTRACT

A handheld surgical endoscope has a disposable, single-use handle, cannula and distal tip. The distal tip includes LED illumination and an imaging module that feeds live video to a re-usable display module that connects off-axis to the disposable handle. A rechargeable battery module also attaches to the handle. The cannula includes two lumens for separate fluid in-flow and out-flow channels, as well as providing a working channel through which a surgical implement can be used. Extruded cannula and molded distal tip parts can be separately formed which aids in manufacturing and assembly. The working channel can have a substantially straight proximal access port.

REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of and incorporates byreference each of the following provisional applications:

U.S. Prov. Ser. No. 62/119,521 filed Feb. 23, 2015;

U.S. Prov. Ser. No. 62/120,316 filed Feb. 24, 2015;

U.S. Prov. Ser. No. 62/139,754 filed Mar. 29, 2015;

U.S. Prov. Ser. No. 62/254,718 filed Nov. 13, 2015;

U.S. Prov. Ser. No. 62/259,991 filed Nov. 25, 2015;

U.S. Prov. Ser. No. 62/275,222 filed Jan. 5, 2016;

U.S. Prov. Ser. No. 62/275,241 filed Jan. 6, 2016;

U.S. Prov. Ser. No. 62/279,784 filed Jan. 17, 2016; and

U.S. Prov. Ser. No. 62/287,901 filed Jan. 28, 2016.

All of the above-referenced provisional patent applications arecollectively referenced herein as “the commonly assigned incorporatedapplications.”

FIELD

This patent specification generally relates mainly to a medical devicefor use in tissue examinations such as in urology or endoscopic surgery.More particularly, some embodiments relate to an integrated, handheld,low-cost medical device having a single-use portion and one or moremultiple-use portions.

BACKGROUND

Conventional endoscopy, or direct vision used to examine the interior ofa hollow organ or cavity of the body, uses a complex lens system fortransmitting the image for the distal tip of the endoscope to a viewer.The lens system is typically an objective lens plus a relay lens systemin the case of rigid endoscopes or a bundle of optic fibers in the caseof flexible endoscopes. In the case of both rigid and flexibleconventional endoscopes, the lens or fiber optic system is relativelyexpensive and is intended to be re-used many times. Therefore, stringentdecontamination and disinfection procedures need to be carried out aftereach use.

Disposable endoscopy is an emerging category of endoscopic instruments.In some cases the manufacture of endoscopes can be made inexpensiveenough to be used on a single patient only. Disposable or single-useendoscopy lessens the risk of cross-contamination and hospital acquireddiseases. Partially disposable endoscopy systems for hysteroscopy arediscussed in U.S. Pat. No. 8,460,182, incorporated by reference herein.A hysteroscope having a disposable probe was offered by EndoseeCorporation of Los Altos, Calif., and is now offered by CooperSurgical,Inc. of Trumbull, Conn., a company that acquired EndoSee Corporation.

The subject matter described or claimed in this patent specification isnot limited to embodiments that solve any specific disadvantages or thatoperate only in environments such as those described above. Rather, theabove background is only provided to illustrate one exemplary technologyarea where some embodiments described herein may be practiced.

SUMMARY

According to some embodiments that are particularly suitable for fieldssuch as urology and endoscopic surgery rather than hysteroscopy, alow-cost medical instrument for examining a patients tissue comprises anelongated, single-use portion that includes: a handle near a proximalend of the elongated portion, which handle is configured and shaped formanual gripping of the instrument while the instrument is being used toexamine the tissue; a shaft having a central axis, a distal end, aproximal end, a first conduit and a second conduit, both first andsecond conduits passing internally through the shaft towards the distalend of the shaft, the first conduit configured to be in fluidcommunication with a first proximal fluid port, and the second conduitcontinuing proximally to provide a substantially straight workingchannel in the second conduit parallel to the central axis from aproximal working channel port on the proximal end of the elongatedsingle-use portion through the handle portion; a distal tip assemblymounted on the distal end of the shaft, the assembly having a distalouter edge rounded to a radius of at least one millimeter, the tipassembly including one or more distal ports in fluid communication withthe first conduit, and a distal working channel port being in fluidcommunication with the second conduit; a light delivery systemconfigured to illuminate the tissues being examined; an electronicimaging module positioned within the tip assembly; one or moreelectrical conductors running through the shaft in electrical connectionwith the imaging module; and an electrical connector on the handleportion in electrical connection with the one or more conductors.

The medical instrument further comprises a multiple-use electronics anddisplay portion including a display, configured for mounting on theelectrical connector of the single-use portion, which results in thedisplay positioned off of the central axis of the shaft.

Some embodiments of the instrument further include one of the followingelements or features and other embodiments further include two, orthree, or more, or all of the following elements or features: (1) thelight delivery system includes at least one LED positioned within thedistal tip assembly; (2) the shaft is extruded from a synthetic polymermaterial; (3) the working channel is dimensioned to allow a surgicalimplement to pass from the proximal working channel port through thesecond conduit and through the distal working channel port so as to beused in a surgical procedure on the patient's tissue; (4) a path throughwhich the surgical implement can pass from the proximal working channelport to the second conduit is straight; (5) a multi-use rechargeablebattery module configured to be removably mounted to said handle portionof the elongated single-use portion; (6) one or more electricalconductors are positioned at least partially within the first conduit;(7) the electrical connector is longitudinally separated from the firstproximal fluid port by at least five centimeters; (8) the electricalconnector is positioned proximally from the first fluid port; (9) theelongated single-use portion further comprises a second proximal fluidport in fluid communication with the second conduit; (10) the distalouter edge of the distal tip assembly is rounded to a radius of at leasttwo millimeters; (11) a central distal surface of the distal tipassembly includes an opening through which the electronic imaging modulecan view tissues being examined, the central distal surface being flator rounded to a radius of at least 5 millimeters; (12) the mounting ofthe multiple-use electronic and display module results in the displaybeing rotatable about an axis perpendicular to the central axis of theshaft; (13) the mounting of the multiple-use electronic and displaymodule results in the display being non-rotatable about any axisparallel the central axis of the shaft: (14) the mounting of themultiple-use electronics and display module results in the display beingrotatable about an axis parallel to the central axis of the shaft; (15)a sensing system configured to sense rotational orientation of thedisplay relative to the electronic imaging module; (16) the multiple-useelectronics and display module includes wireless communication circuitryconfigured to receive video signals originating from the electronicimaging module and to display video images from the imaging module to auser while not physically mounted to the handle portion; (17) theelectrical conductor makes electrical contact with the electronics anddisplay module using male-shaped metallic protrusions that mate withfemale-shaped metallic recesses on the electronics and display module;and/or (18) said multiple-use electronics and display module furtherincludes a fixing mechanism configured to attach the electronics anddisplay module to a users arm, wrist and/or hand.

This patent specification further describes a surgical procedure carriedout using the an embodiment of the instrument described above, theprocedure comprising: inserting the distal tip of the elongatedsingle-use portion into a passageway of the patient; illuminating thepatient's tissues using the light delivery system; electronicallyimaging the patient's tissues using the electronic imaging module; andviewing real-time the electronically imaged tissues on the display.Other examples of the surgical procedure include one or more or all ofthe following additional steps of features: (1) using a surgicalimplement passing through the distal working channel port to carry out aphysical intervention on the patient's tissues; (2) the surgicalimplement is a hypodermic needle and the physical intervention includesinjecting a fluid into the patient's tissues through the hypodermicneedle; (3) the hypodermic needle is positioned within the workingchannel before the distal tip is inserted into the passageway (4) thesurgical implement is positioned within the working channel prior to asterilization and packaging procedure of the elongated single-useportion; (5) the passageway is the patient's urethra; and (6) attachingthe electronics and display module to a user's arm, wrist or hand, androtating the elongated single-use portion about an axis parallel to thecentral axis while maintaining the electronics and display module in anun-rotated position.

According to some embodiments, an endoscope comprises a single-use,disposable portion and a re-usable portion. The single-use, disposableportion comprises at least the following components that are fixedlyassembled into a single unit enclosed in a sterile package configuredfor disposal after a single use on a patient; an elongated handle shapedand dimensioned to be grasped and manipulated by a user's hand, saidhandle having a proximal end and a distal end and further having amounting connector with electrical connector elements, and a batteryconnector; an elongated cannula made of an extruded material, passingthrough the handle and enclosing a first lumen extending distally from alocation inside the handle and a second lumen extending through and bothdistally and proximally from the handle; a tip made of a moldedmaterial, secured at a distal end of the cannula; an imaging assemblyand an illumination assembly mounted in the tip; at least oneside-facing port in the tip in fluid flow communication with the firstlumen for inflow of fluid into the first lumen; a side-facing outflowport in the first lumen, spaced proximally from the tip, configured foroutflow of fluid that has entered the first lumen through theside-facing inflow port in the tip and has passed through the firstlumen in the proximal direction; electrical wires running through thefirst lumen from the electrical connector elements in the handle to theimaging and illumination assemblies in the tip; an outflow port in thetip in fluid flow communication with the second lumen; a side-facinginflow port in the second lumen, spaced in the proximal direction fromthe outflow port in the tip; and a surgical implement port facing in theproximal direction, at the portion of the second lumen that extendsproximally from the proximal end of the handle, configured for insertionof a surgical implement in the distal direction to the tip along astraight insertion path. The re-usable portion of the endoscope in thisembodiment is configured for mounting on the handle and removal from thehandle by hand, and comprises at least: a mounting structure configuredto mechanically mate with the handle's mounting connector and havingelectrical connector elements configured to mate with and establishelectrical contact with the handle's electrical connectors when there-usable portion is mounted on the handle; a rotation coupling betweenthe handle and the re-usable portion configured for relative rotationthe re-usable portion and the single-use portion about at least oneaxis; and a touch-sensitive display screen with associated electroniccircuitry electrically coupled with said female mating elements, saidscreen configured to display video provided by said imaging assembly inthe tip and to respond to touch to control imaging and illuminationoperations at the tip and display operations on the screen.

In some embodiments; the endoscope described in the preceding paragraphfurther includes one or more of the following elements or features: (1)the rotation coupling is configured for relative rotation of there-usable and single-use portions about a two axes that are transverseto each other; (2) one of the two axes is transverse to the longdimension of the handle and the other is along the long dimension of thehandle; (3) tactile feedback is used an indicator of relative positionbetween the re-usable portion and the single-use portion; (4) the handleincludes a depression shaped and dimensioned to receive a clip-onbattery for powering the re-usable portion and the illumination assemblywhen a battery in inserted into said depression and makes electricalcontact with said battery connector and the re-usable portion is mountedon the handle; (5) the single-use portion further includes a batteryconfigured for disposal with the single-use portion, said battery beingsecured in the sterile package in electrical contact with said batteryconnector to power the illumination assembly and the re-usable portionwhen the re-usable portion is mounted on the handle; (6) the connectorelements in the handle are male elements and the connector elements inthe re-usable portion are female connector elements, thereby reducingchances of contamination of the connector elements in the re-usableportion; (7) the tip has a convex end with a circumferential peripherythat is more curved then a central portion to thereby ease insertion ofthe tip in a patient's body; (8) the distal end of the tip has a convexcurvature radius of from 4 to less than 7 mm radius at a central regionand from 1 to less than 4 mm radius at a peripheral area; (9) saidextruded cannula is made of a multi-durometer material that is moreflexible at a distal than a proximal portion of the cannula tofacilitate bending the cannula near the tip; (10) the single-use portionfurther includes a disposable needle for injecting or withdrawingsubstances through said second lumen in fluid flow communicationtherewith, and included in said sterile package; (11) the distal end ofthe cannula comprises a first D-shaped portion in cross-section and asecond D-shaped portion in cross-section that extends to a lesser extentin the distal direction, the first D-shaped portion contains the firstlumen and the second D-shaped portion contains the second lumen; and thetip comprises a cylinder open in the proximal direction to receive thetwo D-shaped portions of the cannula and having an internal stop platefacilitating separation between the first and second lumens; (12) theoutflow port in the first lumen is spaced at least 5 cm in the distaldirection from the electrical connectors in the handle to facilitatekeeping the connectors free of fluid passing through the first lumen;(13) a wiper fitted over the open end of the surgical implement port andconfigured to resist spillage of fluid from the second lumen in theproximal direction when the endoscope is used with a surgical implement;(14) said re-usable portion further comprises a sensor responsive torelative rotation between the re-usable portion and the single-useportion, and at least one of (i) an indicator of current relativepositions of the re-usable and single-use portions, and (ii) a controlchanging orientation of images on the display in relation to currentrelative positions of the re-usable and single-use portions; and (15)said re-usable portion further comprises a fixing mechanism configuredto attach the touch-sensitive display screen to a user's arm; wristand/or hand.

This patent specification further describes an endoscopic method thatcomprises providing a single-use, disposable portion including thefollowing components that are fixedly assembled into a single unitenclosed in a sterile package configured for disposal after a single useon a patient: an elongated handle shaped and dimensioned to be graspedand manipulated by a user's hand, said handle having a proximal end anda distal end and further having a mounting connector with electricalconnector elements, and a battery connector; an elongated cannulapassing through the handle and enclosing a first lumen extendingdistally from a location inside the handle and a second lumen extendingthrough and both distally and proximally from the handle; a tip securedat a distal end of the cannula; an imaging assembly and an illuminationassembly mounted in the tip; at least one inflow port in the tip influid flow communication with the first lumen; an outflow port in thefirst lumen, spaced proximally from the tip, configured for outflow offluid that has entered the first lumen through the inflow port in thetip; electrical wires running through the first lumen from theelectrical connector elements in the handle to the imaging andillumination assemblies in the tip; an outflow port in the tip in fluidflow communication with the second lumen; an inflow port in the secondlumen, spaced in the proximal direction from the outflow port in thetip; and a surgical implement port facing in the proximal direction, atthe portion of the second lumen that extends proximally from theproximal end of the handle, configured for insertion of a surgicalimplement in the distal direction to the tip along a straight insertionpath. The method further comprises: removing the single-use portion fromthe sterile package and mounting by hand thereon a re-usable portionthat comprises a touch-sensitive display screen configured to displayvideo provided by said imaging assembly in the tip and to respond totouch to control imaging and illumination operations at the tip anddisplay operations on the screen; and inserting the cannula tip and thenthe cannula into a patient's body and viewing on the screen images fromthe imaging assembly.

As used herein, the grammatical conjunctions “and”, “or” and “and/or”are all intended to indicate that one or more of the cases, object orsubjects they connect may occur or be present. In this way, as usedherein the term “or” in all cases indicates an “inclusive or” meaningrather than an “exclusive or” meaning.

As used herein the terms “surgical” or “surgery” refer to any physicalintervention on a patient's tissues, and does not necessarily involvecutting a patient's tissues or closure of a previously sustained wound.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thesubject matter of this patent specification, specific examples ofembodiments thereof are illustrated in the appended drawings. It shouldbe appreciated that these drawings depict only illustrative embodimentsand are therefore not to be considered limiting of the scope of thispatent specification or the appended claims. The subject matter hereofwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a right side view of a handheld surgical endoscope, accordingto some embodiments;

FIGS. 2 and 3 are perspective views of a handheld surgical endoscope,according to some embodiments;

FIG. 4 is a proximal view of a handheld surgical endoscope, according tosome embodiments;

FIG. 5 is a right side view showing further details of a handheldsurgical endoscope, according to some embodiments;

FIGS. 6A-6C are perspective, right side and distal views of a distal tipsub-assembly of a handheld surgical endoscope, according to someembodiments;

FIG. 7 is a perspective view of a cannula and tip sub-assembly of ahandheld surgical endoscope, according to some embodiments;

FIGS. 8A-8E are distal, proximal; cross-sectional, bottom andperspective views of a distal tip housing of a handheld surgicalendoscope, according to some embodiments;

FIG. 9 is a diagram showing a handheld surgical endoscope being insertedin a tissue passageway, according to some embodiments:

FIGS. 10A-10C are side views showing further detail of a cannula usedwith a handheld surgical endoscope, according to some embodiments;

FIGS. 11A and 11B are cross sectional views showing further detail ofcannulae used with a handheld surgical endoscope, according to someembodiments;

FIGS. 12A-12D are side and perspective views illustrating a procedure inwhich a surgical device is pre-installed within a handheld surgicalendoscope, according to some embodiments;

FIG. 13 is a schematic diagram illustrating various aspects of ahandheld surgical endoscope, according to some embodiments;

FIG. 14 is a perspective view of a handheld surgical endoscope,according to some embodiments;

FIGS. 15A-15C are perspective views illustrating various aspects of ahandheld surgical endoscope shown in FIG. 14:

FIG. 16 is a perspective view of a handheld surgical endoscope,according to some embodiments;

FIG. 17 is a perspective view of a handheld surgical endoscope shown inFIG. 14 configured for one-handed operation; according to someembodiments; and

FIG. 18 is a perspective view of a handheld surgical endoscopeconfigured for one-handed operation; according to some otherembodiments.

DETAILED DESCRIPTION

A detailed description of examples of preferred embodiments is providedbelow. While several embodiments are described, it should be understoodthat the new subject matter described in this patent specification isnot limited to any one embodiment or combination of embodimentsdescribed herein, but instead encompasses numerous alternatives,modifications, and equivalents. In addition, while numerous specificdetails are set forth in the following description in order to provide athorough understanding, some embodiments can be practiced without someor all of these details. Moreover, for the purpose of clarity, certaintechnical material that is known in the related art has not beendescribed in detail in order to avoid unnecessarily obscuring the newsubject matter described herein. It should be clear that individualfeatures of one or several of the specific embodiments described hereincan be used in combination with features of other described embodimentsor with other features. Further, like reference numbers and designationsin the various drawings indicate like elements.

FIG. 1 is a right side view of a handheld surgical endoscope, accordingto some embodiments. The endoscope 100 includes an elongated cannula 120with a distal tip 112 for inserting into a hollow organ or cavity of thebody. According to some embodiments, a separate tip sub-assembly 110 isattached to the cannula 120 which can be made from an extruded material.Sub-assembly 110 includes an imaging module and one or more LED lightsources for viewing the organ or cavity into which it is inserted. Thetip assembly 110 also includes one or more fluid ports, as well as aworking channel opening through which a surgical device can protrude.The distal end of the cannula 120 can also be slightly bent as shown inbent region 122.

The endoscope 100 includes a handle portion 140 that is sized and shapedfor easy grasping by the endoscope operator (e.g. doctor or othermedical professional). According to some embodiments, the cannula 120includes two or more fluid channels, one of which is fluidly connectedto distal fluid port 132 and another that is fluidly connected toproximal fluid port 172, According to some embodiments, one of thechannels within the cannula 120 can also be used as working channel andis configured to have a straight path via working channel opening 170.The example shown in FIG. 1 includes a surgical device 180 that entersthe working channel via opening 170. It has been found that providing astraight proximal entry port 170 greatly enhances ease of use forinserting various surgical devices.

According to some embodiments, a re-usable display module 150 (FIG. 2)is removably mounted to the handle portion 140 using a connector (notshown), and a re-chargeable battery 160 is removably mounted on theupper side of handle portion 140 as shown. According to someembodiments, apart from the display module 150 and battery 160, theentire endoscope device is made at a relatively low-cost and is intendedto be disposed of after a single-use. By making the tip, cannula, handleand ports of the device 100 all single-use, stringent decontaminationand disinfection procedures as well as the risk of cross-contaminationand hospital acquired diseases can be significantly lessened or avoided.

FIGS. 2 and 3 are perspective views of a handheld surgical endoscope,according to some embodiments. Visible in FIGS. 2 and 3 on endoscope 100is the display module 150 which is removably mounted to the handleportion 140 at the connector 252. Likewise, rechargeable battery 160 isremovably mounted into the handle portion 140 via battery socket 362.The connector 252 and battery socket 362 provide both mechanical andelectrical connections between the handle portion 140 and the displaymodule 150 and battery 160, respectively. According to some embodiments,a rechargeable battery is included within the display module 150 andtherefore a separate battery 160 does not need to be mountable to thehandle portion 140. According to yet other embodiments, non-rechargeablebatteries are used instead of rechargeable battery 160.

In FIG. 3 the connector 252 is shown in more detail, According to someembodiments, the male portions (e.g. ‘pins’) 354 protrude from thehandle portion 140 and the mating female portions (e.g. ‘holes’) 356 arerecessed in the display module 150. Similarly, for electrical connectionbetween the battery module 160 and handle portion 140 the male portions364 (e.g. ridges or pins) are positioned on the handle portion 140,while the female portions 366 (slots or holes) are positioned in batterymodule 160. Providing the male portions of the electrical connectors onthe single-use handle portion 140 and the female portions on there-usable parts—display and battery modules 150 and 160—is beneficialfor purposes of decontamination and disinfection. The handle portion140, cannula 120 and tip 110 together form the single-use portion of theendoscope 100, which is sterilized, for example, during production andis provided to the user in a sealed sterilized packaging. The displaymodule 150 and battery module 160 are intended to be re-used andtherefore are subject to decontamination and/or disinfection procedures.In some cases, it is useful to use disposable sterile covers (e.g. clearpolyethylene bags or sleeves) to cover the display module 150 andbattery module 160 during a surgery or other clinical procedure. In suchcases it is preferable for the male portions of the electricalconnections to reside on the single-use portion which has beensterilized during manufacture and/or packaging.

FIG. 4 is a proximal view of a handheld surgical endoscope, according tosome embodiments. According to some embodiments, the display module 150includes a large central color display area 450 on which the user canview live images from the camera module mounted on the distal tip 112.According to some other embodiments, the display module 150 is rotatableabout axis 452 so as to provide the user with a customizable viewingangle of the display area 450 with respect to the angle of handle 140and cannula 120. For example, in cases where the handle 140 and cannula120 are tipped such that the distal tip is lower than the proximal endof the endoscope, the display module 150 can be rotated in the reversedirection so as to maintain an ergonomic viewing angle of display are450.

FIG. 5 is a right side view showing further details of a handheldsurgical endoscope, according to some embodiments. The cannula 120preferably is made such that it continues through the handle portion 140to the proximal working channel port 170 as indicated by dashed lines520. Electrical wires 522 are shown in dotted line which are positionedwithin one of the fluid channels of cannula 120, until exiting in thevicinity of electrical connector 252. The wires 522 are connected withinthe distal tip sub-assembly 110 to a camera module and LED light sources(not shown). The distal fluid port 132 can be fluidly connected to oneof the fluid channels by way of a cut out 530 in cannula 120. Accordingto some embodiments, the same fluid channel within cannula 120 that isfluidly connected to port 132 is used for carrying the wires 522. Itwill be appreciated that in this case, adequate fluid sealing should beused to ensure fluid within the shared channel does not leak into theconnector 252 where bare, insulated wires, and/or metal contacts arepresent. Adequate fluid sealing is facilitated by the substantiallongitudinal separation distance d measured between the skiving or cutout 530 as shown FIG. 5 (or other fluid exit point from which fluidcould travel internally within the handle) to any bare/exposed metalconnectors. According to some embodiments, the distance d is 50 mm, 75mm or even 100 mm. According to some embodiments, the separationdistance d is at least 75 mm.

FIGS. 6A-6C are perspective, right side and distal views of a distal tipsub-assembly of a handheld surgical endoscope, according to someembodiments. In this example, the distal sub-assembly 610, which cancorrespond to tip sub-assembly 110 in FIGS. 1-5, is shown with aspherically rounded distal tip 612. The assembly 610 includes a workingchannel port 630 through which a surgical instrument can pass. The tip612 also includes a camera port 640 from which imaging module 642 canview the organ or cavity into which the endoscope is inserted. Alsovisible are light ports 650 and 654 through which LEDs 652 and 656 shinelight to illuminate the organ or cavity being imaged using imagingmodule 642. According to some embodiments, illumination can be achievedusing techniques other than LEDs. For example a light fiber guide orpipe can be used to transmit light from a light source in handle 140 (orsome other proximal location). According to some embodiments, two lowerfluid ports are provided, of which one, port 620, is visible in FIGS. 6Aand 6B, In the case there are two fluid channels within cannula 120, anupper fluid channel can be combined with the working channel to providefluid in-flow (i.e. flowing fluid out of the device and into thepatient's organ or cavity). A lower fluid channel within cannula 120 canbe used to provide fluid out-flow (i.e. flowing fluid out of thepatient's organ or cavity and into the device) via the bottom mountedfluid ports (of which port 620 is visible). As described with respect toFIG. 5, supra, this lower fluid channel can also be used to carry wiresthat are connected to the imaging module 642 and LEDs 652 and 656. Asmentioned, the tip 612 is spherically rounded, for example having radiusclose to or equal to the half the width of the cylindrical portion ofthe tip assembly 110. It has been found that a highly rounded, orspherical tip shape such as shown can be beneficial in providing asmooth contour which reduces or eliminates injury to to the patient'stissues in some applications.

FIG. 7 is a perspective view of a cannula and tip sub-assembly of ahandheld surgical endoscope, according to some embodiments. Asdescribed, supra, cannula 120 can be extruded and contain two fluidchannels. In the example shown cannula 120 has an upper lumen 720 and alower lumen 722. Although both upper and lower lumen 720 and 722 areshown in FIG. 7 with a circular cross section, according to someembodiments other cross sections can be used. It has been found that themanufacture of a dual lumen extruded cannula is simple and straightforward. Prior to joining the lumen to the tip sub-assembly 610, asimple 90 degree cut is made in the distal end of cannula 120, leaving a“D” shaped upper half as shown. The D shaped upper half mates with a Dshaped recess in the upper half of sub-assembly 610. The recess includesa stop 712. In this way the D shaped portion of the cannula 120 is“keyed” with the tip assembly 610 such that it is easy to rotationallyand longitudinally align the cannula 120 and the tip sub-assembly 610.Thus the process of joining the tip 610 to cannula 120 is relativelysimple and straightforward. Note that even with the dual lumens, plentyof material remains in cannula 120 to provide structural integrity. Thelocation of the imaging module 642 is also shown in FIG. 7.

FIGS. 8A-8E are distal, proximal, cross-sectional, bottom andperspective views of a distal tip housing of a handheld surgicalendoscope, according to some embodiments. The tip housing 810, forexample, can be used to house the components of the distal tipsubassembly 110 shown in FIGS. 1-3 and 5. The tip housing 810 has arounded outer distal edge, such as tip 610 shown in FIGS. 6A-6C and 7.In contrast, however, the central distal portion of the tip housing 810is flatter and less rounded than tip 610. According to some embodiments,the tip housing 810 is formed by molding and is made from a materialsuch as acrylic, although other suitable materials can be used. FIGS. 8Aand 8B are distal and proximal views, respectively, of the tip housing810. The dimensions of the outer circumference and proximal opening 812,as well as the dimensions and positioning of the working channel port830, camera port 840, light ports 850 and 854, and shelf 860 accordingto some embodiments, are shown. Note that in the example shown in FIG.8B, the camera module is positioned in port 840 which is 1.67 mm indiameter. According to some embodiments, other camera module sizes areused, such as a 1.4 mm diameter camera module. In such cases, the spacewithin the molded tip housing 810 is changed accordingly.

FIG. 8C is a cross sectional view of the distal tip housing along A-A′(shown in FIG. 8B). As can be seen, the outer distal edge 870 of the tiphousing 810 is rounded to a radius of 2.54 mm. According to someembodiments, the distal outer edge 870 is also rounded to be sphericalin shape. It has been found that especially in the case of inserting theendoscope into and through passages such as the urethra, trachea orblood vessels, it is desirable that the outer distal edge 870 of thedistal tip should be rounded since that region of the distal tip bothcontacts and dilates the tissue passage. In such cases, the centralportion 872 of the distal tip can be made less rounded or even flat.Making the central portion 872 less rounded or flat has been found toenhance imaging characteristics over a more spherical overall tip shape(such as shown in FIGS. 6A-6C and 7) since the camera and illuminationis not or significantly less impaired. In the case of a sphericaloverall tip shape (such as shown in FIGS. 6A-6C and 7) where the centralportion of the distal tip is rounded to close the radius of thecylindrical portion of the shaft and/or tip, the camera view from thecamera port and/or the illumination from the light ports can bepartially blocked by the rounded distal tip. In the example shown inFIGS. 8A-8C, the central portion 872 of the distal tip is roundedspherically to a radius of about 6.6 mm. According to some embodiments,other rounding shapes are possible while still providing good tissuecontact properties and good illumination and viewing properties. Forexample, the outer distal edge can be rounded spherically to a radius ofbetween 1 mm to 3.5 mm, while the central portion (which includes mostor all of the camera and light ports) is either flat or roundedspherically to a radius of greater than 4 mm. Also visible in FIG. 8C isthe proximal opening 812 and shelf 860 which are shaped to accept thedistal end of extruded cannula 120 (such as shown in FIGS. 7 and 10B).One of the two lower fluid ports 822 is also visible, which can providefluid out-flow (flowing out of the patient and into the cannula). InFIG. 8D, the dimension and positioning of the two lower fluid ports 820and 822 are visible. FIG. 8E is a prospective view of the molded distaltip housing 810. According to some embodiments, more than two lowerfluid ports are provided for fluid out-flow (flowing out of the patientand into the cannula).

FIG. 9 is a diagram showing a handheld surgical endoscope being insertedin a tissue passageway, according to some embodiments. The distal tip110 and cannula 120 of a surgical endoscope such as shown in FIGS. 1-5is being inserted in passageway 910 within tissue 900. As shown thepassageway 910 is being dilated by the distal tip 110. The distal tip110 has a hybrid rounded shape such as shown in FIGS. 8A-8E such thatits outer distal edge 870 is more rounded (i.e. smaller rounding radius)than the central portion 872 of the distal tip. As discussed, supra,this hybrid rounding profile allows for both good tissue contact anddilation characteristics, and good viewing and illuminationcharacteristics.

FIGS. 10A-10C are side views showing further detail of a cannula usedwith a handheld surgical endoscope, according to some embodiments. FIG.10A is a side view showing example dimensions and shape of cannula 120used in the handheld endoscope 100 shown in FIGS. 1-5. The cannula 120can be extruded and made of a nylon material such as nylon 12 (e.g.Grilamid® L25). The distal end of cannula 120 can include a bent region122 which is beneficial for certain applications and can effectivelyincrease the field of view of the camera fixed to the distal tip whenthe endoscope is rotated about its central longitudinal axis. FIG. 10Bshows further detail of the distal end of the extruded cannula 120. Asdiscussed with respect to FIG. 7, a simple 90 degree cut can be used toform the cut-away region 1020 while leaving a D shaped upper portion1022, Also shown in dotted outline are the upper and lower lumens 720and 722. FIG. 10C shows a further detail in the mid-shaft region wherecut out 530 is made to make a fluid connection between lower lumen 722and a distal fluid port (such as distal fluid port 132 shown in FIGS.1-5), Note that while FIG. 7 shows the cannula 120 being mated tospherically tipped distal tip 610, according to some embodiments, thecannula 120, which is shown in detail in FIGS. 10A-10C and 11A-11B, canalso be mated to a hybrid-rounded distal tip shape such as shown inFIGS. 8A-8E and 9. According to some embodiments, the cannula 120 can bemade such that its stiffness is not constant along its length. Forexample, it may be useful in some clinical applications to provide acannula that is more flexible towards the distal tip and stiffer towardsthe handle. In such cases the cannula 120 can be made from amulti-durometer tubing such as a multi-duro Pebax® or Grilamid®.

FIGS. 11A and 11B are cross sectional views showing further detail ofcannulae used with a handheld surgical endoscope, according to someembodiments. In FIG. 11A, positions and dimensions of upper and lowerlumens 720 and 722 are shown formed within cannula material 1120. Alsovisible are electrical wires 522 positioned within the lower lumen 722.Note at wires 522 in this case include six conductors for connection tothe camera and LEDs on the distal tip sub-assembly, although othernumbers of conductors could be used. In cases where a largercrossectional area of the lower lumen is desired that is not occupied bythe wires 522, other shapes can be used such as shown in FIG. 11B, InFIG. 11B, the lower lumen 1122 has a non-circular cross-section so thatgreater fluid carrying capacity can be provided while stillaccommodating the wires 522.

It has been found that forming the cannula and distal tip partsseparately has significant manufacturing advantages. The cannula can beextruded while the distal tip can be molded. Furthermore post-extrusionpreparation of the extruded cannula is very straightforward, using onlysimple cuts made mid shaft (shown in FIG. 10C) and distal end (shown inFIG. 10B). Also, it has been found that using two lumens as shown inFIG. 11A or 11B, there is plenty of material remaining to providesuitable structural integrity for the cannula. Having two lumens hasbeen found to be suitable for providing separate fluid in-flow andout-flow channels, as well as sufficient space for the video andillumination wires and a working channel.

FIGS. 12A-12D are side and perspective views illustrating a procedure inwhich a surgical device is pre-installed within a handheld surgicalendoscope, according to some embodiments. In FIGS. 12A and 12C, a needle1210 is shown positioned within the upper lumen 720 of endoscope 100which is being used as a working channel. According to some embodiments,the needle 1210 is installed into the position shown in FIGS. 12A and12C prior to insertion of the endoscope 100 into the patient. Forexample, the needle 1210 could be installed into the endoscope 100 inthe clinic or doctor's office in preparation for the medical procedure.According to some other embodiments, the needle 1210 or other surgicalimplement is pre-installed in the cannula as shown during manufacture(e.g. on the production line) or otherwise, prior to sterile packagingof the single-use portion of the endoscope 100. While in the positionshown in FIGS. 12A and 12C, the distal tip 110 of endoscope 100 isinserted into the patient (such as shown in FIG. 7). After the distaltip 110 is positioned in the desired location (e.g. in the desiredhollow organ or cavity of the body), the needle 1210 is pushed into thepatient's tissue. FIGS. 12B and 12D show side and perspective views,respectively, of the needle 1210 protruding from the working channelport 830 of the distal tip 110. In the case where needle 1210 is ahollow needle (e.g. hypodermic needle), than the needle 1210 can be usedto inject substance into the penetrated tissue and/or extract fluidsfrom it. Note that in FIGS. 12A-12D the distal tip 110 has a hybridrounded shaped tip housing 810 such as shown in FIGS. 8A-8E, having itsouter distal edge more rounded than the central portion of the distaltip. A non-circular lower lumen 1122 is shown in this case. Imagingmodule 642 and LEDs 652 and 656 are also shown positioned within tip110.

FIG. 13 is a schematic diagram illustrating various aspects of ahandheld surgical endoscope, according to some embodiments. The cannula120 is shown with upper fluid lumen 720 and lower fluid lumen 722. Forclarity the handle 140 is not shown in detail but is functionally markedwith a dashed rectangle. As can be seen, the upper lumen 720 is in fluidcommunication with proximal fluid port 172, working channel opening 170and distal working channel port 830. The upper fluid lumen 720 isconfigured to be used for both passage of a surgical instrument and forfluid in-flow. The fluid in-flow path is from proximal fluid port 172,through lumen 720, out of tip 110 via distal working channel port 830and into the patient, as shown by the dashed arrows. Passage of asurgical device (e.g. a needle) through lumen 720 is via working channelopening 170. On the proximal end of surgical endoscope 100 a wiper 1340is shown attached to working channel opening 170 and and a cap 1350 isshown attached to proximal fluid port 172. When fluid port 172 is beingused for introducing fluid into the patient, a syringe or other suitabledevice would be connected to port 172 instead of a cap. When a surgicalinstrument is being introduced through opening 170 then a wiper, such aswiper 1340, can be used which has an opening to allow for passage of theinstrument. According to embodiment a duckbill valve can be provided inaddition to or instead of wiper 1340, although a properly sized wiperwill generally form better fluid seal than a duckbill when an instrumentis present. When an instrument is not present a cap, such as cap 1350can also be used on opening 170. Note that in FIG. 13, proximal fluidport 172 is shown angled slightly upwards instead of downwards as shownin other figures such as FIGS. 1-5, 14, 15B and 16. In general, theorientation of the fluid ports 132 and 172 (downwards, upwards or to aside) is a matter of design choice depending upon ergonomic and otherconsiderations of the expected clinical application.

The lower fluid lumen 722 is configured to be used for both carrying thewires 522 as well as for fluid out-flow. The fluid out-flow path, alsoshown by dotted arrows, is out of the patient, through the two lowerfluid ports 820 and 822 (of which only port 820 is visible), throughlower lumen 722, through cut out 530 and out through distal fluid port132. Note that although the fluids carried by the lumens 720 and 722 isoften a liquid, in some embodiments one or both lumens can be used tocarry gas (e.g. CO₂) or a mixture of liquid and gas. The wires 522 passfrom the camera and LEDs in the distal tip 110, through lumen 722, outthrough cut out 1320 to connector 252. Note that between the cut out1320 and connector 252 the wires 522 still reside within the handle 140.According to some embodiments a sealant 1322 is used within the handle140 to prevent any fluid from passing within the handle 140 from lumen722 to the connector 252 where liquid could cause a short or othermalfunction by contacting bare wires or un-insulated connectors. Lumen720 is also blocked by sealant 1330 to prevent any fluid from exitingdistally into the handle 140. Note that sealing, such as using sealant1322 and 1330 is used to prevent fluid leaking from lumen 722 intointernal portions of the handle 140. In general, liquid leaking insidethe handle 140 towards bare/un-insulated metal contacts or wires can bemore troublesome than liquid traveling outside the handle 140 (such asdripping from openings 170 or 172) since such liquid is not visible. Toprevent such internal leaks, an adequate distance d is provided wherethe distance d is measured between internal fluid cut out 530 or otherpoint where fluid could leak internally to bare/uninsulated metal (suchas connector pins, sockets, bare wire portions) and connector 252.

FIG. 14 is a perspective view of a handheld surgical endoscope,according to some embodiments. The display module 150 is rotatable aboutaxis 452 as shown by arrow 1452 and as depicted supra, e.g. in FIG. 4.In addition, however, in the case shown in FIG. 14 the display module150 is also rotatable about the handle's longitudinal axis 1402 as shownby solid arrow 1404 and dotted arrows 1406 and 1408. Example alternatepositions for display module 150 are shown in dotted outlines 1416 and1418. The positioning of the display module 150 at position 1418 can beparticularly ergonomic in some cases, such as where the operator is lefthanded. In other cases the entire endoscope 1400 is sometimes rotatedabout axis 1402 while performing the surgical procedure or inspectingtissues. For example, rotating the endoscope about axis 1402 caneffectively increase the field of view of the camera fixed to the distaltip because of the bent section near the distal end of the cannula. Whenthe endoscope is rotated, the display module can be moved relative tothe handle 140 in order to maintain the display in a relativelystationary position, or other ergonomic position.

FIGS. 15A-15C are perspective views illustrating various aspects of ahandheld surgical endoscope shown in FIG. 14. In FIG. 15A, ring 1502 isvisible which wraps around spindle 1522 shown in FIG. 15B. The ring 1502has a plurality of pins 1520 on its inner surface that make electricalcontact with the plurality of contact rings 1524 on spindle 1522.O-rings are provided on either side of the electrical contact of whichO-ring 1540 is visible in FIG. 15B.

Note that in cases where display module 150 is fixed to the handle (i.e.not rotatable about the main axis of the endoscope, as in endoscope 100shown in FIGS. 1-5), the video display is always in a fixed alignmentwith the camera module at the tip. However in cases where display module150 is rotatable about the main axis 1402 of the endoscope (such as withendoscope 1400 shown in FIGS. 14 and 15A-15C), the display can be out ofalignment with the camera module. When the endoscope 1400 is rotatableduring a surgical procedure it is therefore useful to have some feedbackto the user as to the rotational position of the bent portion of thetip. In such cases the fluid ports 132 and 172 can serve as an tactilefeedback to aid user. According to some embodiments, in cases wheredisplay module 150 is rotatable about the main axis 1402 of theendoscope (such as with endoscope 1400 shown in FIGS. 14 and 15A-15C),an optical sensor 1552, shown in FIG. 15C, can be used to sense therotational position of the display module 150 with respect to the handle140 by reading an encoded pattern 1550 on the outer surface of spindle1524. The rotational position of the display module 150 relative to thehandle 140 (and therefore also to the camera module) can be used toautomatically maintain alignment between the video image being displayedon display 450 and the camera module. According to some otherembodiments, the rotational position information can instead be used todisplay a visual marker to the user on display 450 to provide furtherfeedback.

FIG. 16 is a perspective view of a handheld surgical endoscope,according to some embodiments. In FIG. 16 the endoscope 1600 has aremovable and re-usable display module 1650, just as in the case ofdisplay module 150 in endoscopes 100 and 1400 shown in FIGS. 1-5 and14-15C, respectively. However, in the case of endoscope 1600, thedisplay module 1650 and the handle 140 can communicate with each othervia wi-fi or other wireless connection technology. In order to minimizethe single-use portion of the endoscope 1600, sensor data from thecamera module is transmitted via wireless transmission module 1642 inthe handle 140 to the wireless transmission module 1652 on the displaymodule 1650. Complex video functions such as video compression andrecording can be carried out by the display module 1650. Some controlprocessing is also carried out by the handle 140 but little or no userinterface functionality need to be included in handle 140. For exampleuser interface controls for video on/off, record, lighting, and exposurecontrols can all be provided via a touch screen graphical user interfaceon display module 1650. According to some embodiments, the wirelesstransmission module can alternatively be positioned in battery module160 as shown by transmission module 1644. Positioning the transmissionmodule 1644 in the re-usable battery module 160 instead of on the singleuse handle 140 further decreases the cost and complexity of the singleuse portion of endoscope 1600.

FIG. 17 is a perspective view of a handheld surgical endoscopeconfigured for typically one-handed operation, according to someembodiments. The endoscope 1400 has a display module 150 that isrotatable relative to the handle 140 about a main handle axis 1402 suchas shown by arrow 1704. In addition, however, the display module 150 hasa strap 1710 attached via mounting 1712 which is dimensioned to wraparound the hand or wrist of a user as shown in FIG. 17. By attaching thedisplay module 150 to the hand or wrist, the user can easily use onehand to rotate the handle cannula and tip of the endoscope 1400, asshown by the dashed arrows 1706 and 1708, while maintaining the displaymodule 150 in a fixed or relatively fixed position for easy viewing. Inparticular, the strap 1710 effectively prevents display module 150 fromrotating about axis 1402 despite the handle 140 and cannula 120 beingrotated about the main longitudinal axis of cannula 120, Note that thelongitudinal axis of cannula 120 and longitudinal axis of the handle 140(axis 1402) will be parallel to each other but not necessarily the samedepending on the design of the handle 140. Furthermore, by positioningthe mounting 1712 near the axis 452, the display module 150 can still berotated about that axis, which is perpendicular to the cannula axis1402, as shown by arrow 1752. Allowing for one-handed operation frees upthe user's other hand for other tasks such as manipulating a surgicalimplement such as surgical device 180 shown in FIG. 17 entering theworking channel via opening 170. Although the display is shown in FIG.17 as being attached to a user's left hand, the same or similar strap orfixing mechanism can be used to attach the display to the user's righthand, According to some embodiments, other techniques can be used toattach the display module 150 to the wrist or hand of the user,including bands and/or elastic loops which can be attached via snaps orVelcro, and open or closed ended clips.

FIG. 18 is a perspective view of a handheld surgical endoscopeconfigured for typically one-handed operation, according to some otherembodiments. In FIG. 18 the endoscope 1800 has a removable and re-usabledisplay module 1850 that communicates with the handle 140 while notattached to the handle 140 either using a wireless communication unit1852 or a flexible cable 1860. If wireless communication is used thenthis unit can be similar or identical to endoscope 1600 shown in FIG.16. The display module 1850 has two metal clips 1810 and 1812 that aredimensioned and shaped to attach to the user's forearm as shown in FIG.18. When attached to the user's forearm, the endoscope 1800 allows forone-handed operation of the endoscope similar to as described withrespect to FIG. 17, including the ability to rotate the handle, cannulaand tip about the main longitudinal axis, while maintaining the displayin a fixed or relatively fixed orientation. As in the case of FIG. 17,the display module can be attached to the user's right or left arm(although attachment to the left forearm is shown in FIG. 18).Furthermore, other techniques can be used to attach the display module150 to the user's left or right forearm, including, for example, clipsotherwise similar to clips 1810 and 1812 but made of a non-metallicmaterial, straps, bands, and/or elastic loops which can be attached viasnaps or Velcro.

Although the foregoing has been described in some detail for purposes ofclarity, it will be apparent that certain changes and modifications maybe made without departing from the principles thereof. It should benoted that there are many alternative ways of implementing both theprocesses and apparatuses described herein. Accordingly, the presentembodiments are to be considered as illustrative and not restrictive,and the body of work described herein is not to be limited to thedetails given herein, which may be modified within the scope andequivalents of the appended claims.

1-43. (canceled)
 44. An endoscope comprising: a single-use unitcomprising a handle with an opening at a proximal end thereof and acannula extending along a straight longitudinal axis from said openingand through said handle and distally out of the handle, and having animaging module at a distal tip; a multiple-use display unit removablymounted on and supported by said handle and comprising a touch-sensitivedisplay screen; wherein: said display unit and said handle includerespective mechanical connectors that engage each other to removablymount the display unit on the handle by sliding motion relative to eachother; said display unit is to offset from said longitudinal axis whenmounted on said handle; said display unit further includes an electricalconnector with male pins and said handle further includes an electricalconnector with female receptors making electrical contact with said pinsas a result of said sliding motion as the display unit is being mountedon said handle; said display unit includes a battery powering saidscreen and said imaging module; said cannula includes a working channelextending from said opening at the proximal end of the handle to saiddistal tip of the cannula; said working channel is configured for asurgical device to enter said opening at the proximal end of the handleand pass through the handle along said longitudinal axis; saidtouch-sensitive screen is configured to respond to touch commands tocontrol taking of images with said imaging module and is furtherconfigured to display said images; said cannula further includes a fluidchannel with a proximal port that is spaced distally at least 50 mm fromsaid electrical connector of the handle, and a distal port at saiddistal tip of the cannula; whereby said display unit is removabletool-free from said handle using said sliding motion, for disposal ofthe handle and cannula after a medical procedure therewith, and ismounted tool-free on a new handle for another medical procedure.
 45. Theendoscope of claim 44, wherein said imaging module includes anillumination device and said screen is configured to respond to touchcommands to control a degree of illumination by said illuminationdevice.
 46. The endoscope of claim 44, wherein said imaging moduleincludes an imaging device and said screen is configured to respond totouch commands for exposure control of said imaging device.
 47. Theendoscope of claim 44, wherein said screen is configured to respond totouch commands to turn on and off said imaging module.
 48. The endoscopeof claim 44, wherein said distal tip of the cannula is angled relativeto said longitudinal axis.
 49. The endoscope of claim 44, in which saidcannula and said display unit are configured for rotation relative toeach other about said longitudinal axis.
 50. The endoscope of claim 49,including wires between said imaging module and an attachment of saiddisplay unit to said handle, said wires running in said fluid channel.51. The endoscope of claim 44, in which said touch-sensitive screen isconfigured to rotate relative to said handle but only about an axistransverse to said longitudinal axis.
 52. The endoscope of claim 44, inwhich at least a portion of said handle is elongated and extends alongsaid longitudinal axis.
 53. The endoscope of claim 44, in which saidimaging module and said display unit are configured to communicate witheach other when the display unit is not mounted on the handle, saidcommunicating including sending commands from the display unit to theimaging module and receiving images at the display unit taken with saidimaging module.
 54. An endoscope comprising: a handle with an opening ata proximal end thereof and a cannula extending along a straightlongitudinal axis from said opening and through said handle and distallyout of the handle, said cannula having a curving distal tip with animaging module; a display unit removably mounted on said handle andcomprising a touch-sensitive display screen; wherein: said display unitand said handle include respective mechanical connectors that engageeach other to removably mount the display unit on the handle by slidingmotion relative to each other; said display unit is off saidlongitudinal axis when mounted on the handle; said display unit and saidhandle further include respective electrical connectors makingelectrical contact with each other as a result of said sliding motion asthe display unit is being mounted on said handle; said display unitincludes a battery powering said screen and said imaging module; saidcannula includes a working channel extending from said opening at theproximal end of the handle to said distal tip of the cannula; saidworking channel is configured for a surgical device to enter saidopening at the proximal end of the handle and pass through the handlealong said longitudinal axis; said touch-sensitive screen is configuredto respond to touch commands to control said imaging module and isfurther configured to display said images; and said cannula furtherincludes a proximal fluid port that is spaced distally at least 50 mmfrom said electrical connector of the handle; whereby said display unitbeing removable tool-free from said handle for disposal of the handleand cannula after a medical procedure therewith and for tool-freemounting on a new handle for another medical procedure.
 55. Theendoscope of claim 54, in which the cannula further includes a fluidchannel communicating with said proximal fluid port, and a distal portof said fluid channel at said distal tip of the cannula.
 56. Theendoscope of claim 55, further including wires running in said fluidchannel from said imaging module to said electrical connector of thehandle.
 57. The endoscope of claim 54, in which the cannula's distal tiphas a convex distal face with a circumferential periphery that is morecurved than a central portion.
 58. The endoscope of claim 54, in whichthe distal end of the tip has a convex curvature radius from 4 to lessthan 7 mm at a central region and from 1 to less than 4 mm at aperipheral area.
 59. The endoscope of claim 54, in which said handle isfree of manual devices controlling operational parameters of saidimaging module.
 60. The endoscope of claim 54, further including aremovable cap closing said opening at the proximal end of the handle.61. An endoscopic method comprising: providing a single-use, disposableunit comprising the following components that are fixedly assembled intoa single unit enclosed in a sterile package and are configured fordisposal after a single use on a patient: a handle shaped anddimensioned to be grasped and manipulated by a user's hand; said handlehaving a proximal end with an opening and a distal end and furtherhaving a mechanical connector and electrical connector both intermediatethe proximal and distal ends of the handle; a cannula extending distallyfrom the opening at the proximal end of the handle and passing throughthe handle and having a working channel extending distally from saidopening to a distal tip of the cannula; an imaging assembly and anillumination assembly mounted in the cannula's distal tip; removing thesingle-use portion from the sterile package and mounting by hand thereona re-usable display unit that comprises a touch-sensitive display screenconfigured to display video images provided by said imaging assembly inthe cannula tip and to respond to touch to control imaging operations ofsaid imaging module and display operations on the screen; and insertingthe cannula tip into a patient's body; operating said imaging modulesolely by touch commands entered through said touch-sensitive screen andviewing on the screen images from the imaging assembly.
 62. Theendoscopic method of claim 61, further comprising inserting a surgicaltool along a straight path through said opening at the proximally end ofthe handle and into at least a proximal portion of said working channel.63. The endoscopic method of claim 61 including communicating commandsfrom the display unit to the imaging assembly and receiving at thedisplay unit images from the imaging assembly while the display unit isnot mounted on said handle.